Dendreon reported detailed results from the late-stage IMPACT trial for Provenge (sipuleucel-T) in men with advanced prostate cancer, which showed that the immunotherapy met the study's primary endpoint by extending median survival by 4.1 months, compared with placebo. Patients taking Provenge had a 22.5-percent reduction in risk of death compared with those in the control arm, exceeding the threshold of 22-percent improvement that had been set in an agreement with the FDA.
The randomised, double-blind study involved 512 men with advanced metastatic prostate cancer who were not responding to hormone therapy. Data showed that patients who received Provenge had a median survival of 25.8 months compared to 21.7 months for those who received placebo; and three-year survival for patients who took Dendreon's prostate cancer vaccine was improved by 38 percent, compared with the control group. The company plans to file the data with the FDA in the fourth quarter.
David Penson, who presented the results Tuesday at the annual meeting of the American Urological Association (AUA) and who treated some patients in the study, commented that he expects Provenge to replace chemotherapy in the US if the treatment is approved by the FDA.
In reference to comparisons with the use of sanofi-aventis' Taxotere (docetaxel) in men with prostate cancer, David Heupel of Thrivent Large Cap Growth Fund said it is unclear if patients taking Provenge in the IMPACT study had disease as advanced as those on whom Taxotere has been tested. Data for sanofi-aventis' drug have shown a survival improvement of around 3 months, compared with placebo.
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